MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/810/085

Device Problem Material Perforation (2205)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/30/2017

Event Type  malfunction  

Manufacturer Narrative

Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that the cuff of a portex® blue line ultra® tracheostomy tube "perforated".The cuff was "drilled into the patient".The fault was identified eight days after placement.It was noted that the patient was comfortable and "without respiratory effect".No injury was reported.

Manufacturer Narrative

One portex® blue line ultra® tracheostomy tube was received in used condition.The sample was visually inspected at a distance of 12 to 24 inches.No holes were detected.The cuff was inflated and submerged under water.A leak was found in the cuff.A review of the manufacturing and quality processes was conducted and was considered adequate and correct.Per previous complaints, retraining of the production personnel was conducted in order to reinforce the inflation test operation.Based on the evidence, the complaint was confirmed.The root cause is unknown.

• Brand Name: PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6718474
• MDR Text Key: 80215260
• Report Number: 3012307300-2017-01505
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/03/2021
• Device Catalogue Number: 100/810/085
• Device Lot Number: 3146361
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1